Strides Pharma Science share price rose 4 percent at Rs 488.95 in the early trade on September 15 after its stepdown wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, received tentative approval for Dolutegravir 50mg tablets from the United States Food & Drug Administration (USFDA). The product is the bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Tivicay Tablets of ViiV Healthcare Company.
The products will be manufactured at the company’s facility in Bengaluru and conversion of this tentative approval to a full approval is expected upon expiry of the constraining patents.
The company has 260 cumulative ANDA filings (including the recently acquired portfolio from Endo at Chestnut Ridge) with the USFDA, of which 230+ ANDAs have been approved.
The company is eyeing around 60 new product launches over the next three years in the US.
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On September 9, the said subsidiary had received approval for Sevelamer Carbonate for Oral Suspension USP, 0.8g and 2.4g, from the USFDA. On September 7, the company board approved acquisition of 100-percent shareholding in Strides Pharma Services Private Limited (SPSPL).
SPSPL was a wholly owned subsidiary (WOS) of Arco Lab Private Limited, which is a WOS of the company. Post the said acquisition, SPSPL shall be a direct WOS of the company.
In August, Strides Pharma Global Pte had received approval from the US health regulator for generic Mycophenolate Mofetil for oral suspension indicated in organ transplant patients to avoid rejection.
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